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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study, no GLP, short report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technically pure

Test animals

Species:
rabbit
Strain:
other: white Wiener
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BASF
- Age at study initiation: no data
- Weight at study initiation: 2,3 kg (mean)

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 - 2 g/ animal
- Concentration (suspesion): 50 %

Duration of treatment / exposure:
20 h
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²

- Type of wrap if used: semi-occlusve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results
Irritation parameter:
other: No numbers were given
Remarks on result:
other: In 3 of 4 animals very slight to slight reddening was observed
Irritant / corrosive response data:
In 3 of 4 animals very slight to slight, transient reddening was observed 24 h after treatment
Other effects:
Blue discoloration by the substance

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material not irritant after semi-occlusive treatment of rabbit skin for 20 hours.
Executive summary:

The skin irritation hazard was tested in rabbits by semi-occlusive application of the test material for 20 hours. Animals were treated with a 50% aqueous paste. Observations werer made after 1, 5 oand 15 minutes of contact to the skin. Afterwards animals were treated for 20 hours.

After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbits. Additionally the skin was blue discolored by the test material.